title: Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury.
abstract: OBJECTIVE
  To determine the long-term effects of the cough stimulation system.
  
  
  METHODS
  Nonrandomized clinical trial of subjects using the study device well beyond the period of close follow-up.
  
  
  METHODS
  Use of the study device in the home setting.
  
  
  METHODS
  Subjects (N = 10) implanted with the device for a minimum of 2 years (mean 4.6 ± 0.6 years).
  
  
  METHODS
  Application of daily stimulation.
  
  
  METHODS
  Airway pressure generation and other clinical assessments including ease in raising secretions, life quality, caregiver support, and incidence of respiratory tract infections were measured at 1 year and mean 4.6 years after implantation.
  
  
  RESULTS
  Each subject continued to use the device on a regular basis. During SCS, mean maximum airway pressures were 103.1 ± 20.4 and 107.7 ± 23.0 cm H₂O at the 1-year and mean 4.6-year follow-up points, respectively (P < 0.05 compared with pre-implant and not significantly different (NS) compared with 1-year follow-up). Benchmarks related to ease in raising secretions and improvements in life quality related to respiratory care were maintained at the mean 4.6 year follow-up. The need for trained caregivers to provide other means of secretion management remained significantly below the pre-implant values (P < 0.05). The incidence of acute respiratory tract infections remained low at 0.2 ± 0.1 events/year, which is significantly below the pre-implant value of 1.4 ± 0.3 events/year (P < 0.05).
  
  
  CONCLUSIONS
  Subjects continued to use the system on a long-term basis beyond the period of close follow-up and to continued derive significant clinical benefits.
authors.forename: Anthony F
authors.initials: AF
authors.lastname: DiMarco
authors.forename: Krzysztof E
authors.initials: KE
authors.lastname: Kowalski
authors.forename: Dana R
authors.initials: DR
authors.lastname: Hromyak
authors.forename: Robert T
authors.initials: RT
authors.lastname: Geertman
mesh_terms: D000328:Adult; D015331:Cohort Studies; D003371:Cough / Q000209:etiology* / Q000628:therapy*; D004565:Electroconvulsive Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012123:Pulmonary Ventilation / Q000502:physiology; D012141:Respiratory Tract Infections / Q000209:etiology; D013116:Spinal Cord / Q000502:physiology*; D013119:Spinal Cord Injuries / Q000150:complications*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Cough; Expiratory muscles; Spinal cord stimulation